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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, antistick
510(k) Number K040545
Device Name OTTER SAFETY SYRINGE
Original Applicant
OTTER (CHINA) TECHNOLOGY CO., LTD.
po box 560
stillwater,  MN  55082
Original Contact elaine duncan
Regulation Number880.5860
Classification Product Code
MEG  
Date Received03/02/2004
Decision Date 04/22/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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